| TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM. (P140015/S003) | Tandem Diabetes Care, Inc. | 2015-10-08 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S009) | Scott Laboratories, Inc. | 2015-10-08 |
| FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD (P960004/S059) | Boston Scientific | 2015-10-08 |
| T SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S002) | Tandem Diabetes Care, Inc. | 2015-10-08 |
| MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP (P890055/S061) | Intera Oncology | 2015-10-08 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM (P140015/S004) | Tandem Diabetes Care, Inc. | 2015-10-08 |
| ADVISA, ENRHYTHM MRI (P980035/S437) | Medtronic, Inc. | 2015-10-07 |
| ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II. INSYNC MARQUIS, PROTECTA/ PROTECTA XT DR (P980016/S547) | Medtronic Cardiac Rhythm Disease Management | 2015-10-07 |
| CARELINK PATIENT MONITOR 2490G, CARDIOSIGHT READER, CARELINK EXPRESS, REVEAL DX/XT, REVEAL LINQ INSERTABLE CARDIAC MONIT (P890003/S336) | Medtronic, Inc. | 2015-10-07 |
| CAPSUREFIX MRI LEAD (P090013/S201) | Medtronic, Inc. | 2015-10-07 |
| INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S355) | Boston Scientific | 2015-10-07 |
| EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD ) (P110042/S050) | Boston Scientific Corporation | 2015-10-07 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S279) | Medtronic, Inc. | 2015-10-07 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S139) | Medtronic, Inc. | 2015-10-07 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S055) | Endologix, LLC | 2015-10-07 |
| REVO MRI (P090013/S198) | Medtronic, Inc. | 2015-10-07 |
| VENASEAL CLOSURE SYSTEM (P140018/S001) | Medtronic Vascular, Inc. | 2015-10-07 |
| INCEPTA CRT D, ENERGEN CRT D, PUNCTUA CRT-D, DYNAGEN CRT-D, INOGEN CRT D, ORIGEN CRT-D (P010012/S400) | Boston Scientific Corp | 2015-10-07 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S293) | ABBOTT MEDICAL | 2015-10-07 |
| MAXIMO II CRT-D, CONCERTO, CONCERTO II, CONSULTA, INSYNC II MARQUIS, INSYNC III MARQUIS, INSYNC MAXIMO, INSYNC SENTRY, (P010031/S510) | Medtronic Cardiac Rhythm Disease Management | 2015-10-07 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S363) | ABBOTT MEDICAL | 2015-10-07 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110002/S010) | Highridge Medical, LLC | 2015-10-06 |
| JUVEDERM VOLUMA XC (P110033/S015) | Allergan | 2015-10-06 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S007) | Scott Laboratories, Inc. | 2015-10-06 |
| NEXGEN LPS-FLEX/ LPS MOBILE BEARING KNEE SYSTEM (P060037/S038) | Zimmer, Inc. | 2015-10-06 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S048) | Allergan | 2015-10-06 |
| MOBI-C CERVICAL DISC PROSTHESIS (P110009/S010) | Highridge Medical, LLC | 2015-10-06 |
| AUGMENT BONE GRAFT (P100006/S001) | Biomimetic Therapeutics, LLC | 2015-10-05 |
| ON-X PROSTHETIC HEART VALVE (P000037/S043) | On-X Life Technologies, Inc. | 2015-10-05 |
| EXABLATE (P040003/S016) | Insightec, Ltd. | 2015-10-05 |
| OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM) (P100034/S013) | Novocure, GmbH | 2015-10-05 |
| DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD (P960040/S354) | Boston Scientific | 2015-10-02 |
| SOF SENSOR (P980022/S140) | Medtronic Minimed | 2015-10-02 |
| ADHESIVE (P830061/S122) | Medtronic Cardiac Rhythm Disease Management | 2015-10-02 |
| GYNECARE THERMACHOICE II BALLOON CATHETER (P970021/S043) | Gynecare, Inc. | 2015-10-02 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S066) | Zoll Manufacturing Corporation | 2015-10-02 |
| END CAP,UPSIZING SLEEVE (P900061/S137) | Medtronic Cardiac Rhythm Disease Management | 2015-10-02 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S013) | Medinol, Ltd. | 2015-10-02 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S065) | Medtronic, Inc. | 2015-10-02 |
| DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA (P920015/S162) | Medtronic, Inc. | 2015-10-02 |
| CAPSUREFIX MRI LEAD (P090013/S199) | Medtronic, Inc. | 2015-10-02 |
| SUREFIX LEAD (P930039/S137) | Medtronic, Inc. | 2015-10-02 |
| ENLITE SENSOR (P120010/S001) | Medtronic, Inc. | 2015-10-02 |
| PD-L1 IHC 22C3 PHARMDX (P150013) | Agilent Technologies, Inc. | 2015-10-02 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S001) | Nevro Corporation | 2015-10-02 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S002) | Boston Scientific Corporation | 2015-10-02 |
| MYOCARDIAL PACING LEAD (P120017/S001) | Medtronic, Inc. | 2015-10-02 |
| ATTAIN ABILITY LEAD (P080006/S084) | Medtronic, Inc. | 2015-10-02 |
| SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD (P890003/S337) | Medtronic, Inc. | 2015-10-02 |
| DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D (P010012/S399) | Boston Scientific Corp | 2015-10-02 |
| QUARTET FAMILY OF CRT LEADS (P030054/S290) | ABBOTT MEDICAL | 2015-10-02 |
| MINIMED 530G INSULIN PUMP (P120010/S046) | Medtronic, Inc. | 2015-10-02 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD (P010015/S280) | Medtronic, Inc. | 2015-10-02 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003) | Boston Scientific Corporation | 2015-10-02 |
| RADIESSE (P050037/S062) | Merz North America, Inc. | 2015-10-01 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S014) | Medinol, Ltd. | 2015-10-01 |
| BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S079) | Boston Scientific | 2015-10-01 |
| COAPTITE (P040047/S042) | Merz North America, Inc. | 2015-10-01 |
| RADIESSE, RADIESSE(+), RADIESSE (P050052/S072) | Merz North America, Inc. | 2015-10-01 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S085) | Boston Scientific Corp | 2015-10-01 |
| JUVEDERM ULTRA XC INJECTABLE GEL (P050047/S044) | Allergan | 2015-09-30 |
| JUVEDERM VOLUMA XC (P110033/S019) | Allergan | 2015-09-30 |
| ANGIO-SEAL (P930038/S078) | Terumo Medical Corporation | 2015-09-30 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S050) | Allergan | 2015-09-30 |
| ELCA CORONARY LASER ATHERECTOMY CATHETERS (P910001/S080) | Spectranetics Corp. | 2015-09-30 |
| MYCARELINK MONITOR 24950 (P890003/S334) | Medtronic, Inc. | 2015-09-30 |
| PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR (P970003/S185) | LivaNova USA, Inc. | 2015-09-30 |
| VASCADE VASCULAR CLOSURE SYSTEM (VCS) (P120016/S014) | Cardiva Medical, Inc. | 2015-09-30 |
| ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM (P930014/S084) | Alcon Laboratories, Inc. | 2015-09-29 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (OTW AND MR) (P100023/S122) | Boston Scientific Corp | 2015-09-29 |
| SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S217) | Medtronic, Inc. | 2015-09-29 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S438) | Medtronic, Inc. | 2015-09-29 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S057) | Medtronic Vascular | 2015-09-29 |
| CRYOABLATION SYSTEM (P020045/S067) | Medtronic Cryocath, LP | 2015-09-28 |
| RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK (P040024/S084) | Q-Med AB | 2015-09-25 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S033) | Boston Scientific Corp | 2015-09-25 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S046) | Medtronic | 2015-09-25 |
| TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM. (P990040/S021) | Cerenovus, Inc. | 2015-09-25 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S032) | Smith & Nephew, Inc. | 2015-09-25 |
| RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK (P040024/S085) | Q-Med AB | 2015-09-25 |
| COLOGUARD (P130017/S004) | Exact Sciences Corporation | 2015-09-25 |
| OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P860047/S031) | Bausch & Lomb, Inc. | 2015-09-25 |
| GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S091) | ABBOTT MEDICAL | 2015-09-25 |
| RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK (P040024/S082) | Q-Med AB | 2015-09-24 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S019) | Cryolife, Inc. | 2015-09-24 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S033) | Ventana Medical Systems, Inc. | 2015-09-24 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S001) | Ventana Medical Systems, Inc. | 2015-09-24 |
| MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS (P030053/S030) | Mentor Corp. | 2015-09-24 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S023) | Ventana Medical Systems, Inc. | 2015-09-24 |
| ANIMAS VIBE SYSTEM (P130007/S005) | Animas Corp. | 2015-09-24 |
| VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL) (P020055/S017) | Ventana Medical Systems, Inc. | 2015-09-24 |
| PROGENSA PCA3 ASSAY (P100033/S006) | Gen-Probe Incorporated | 2015-09-24 |
| ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P140023/S002) | Roche Molecular Systems, Inc. | 2015-09-24 |
| XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S128) | Abbott Vascular, Inc. | 2015-09-23 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S037) | Dexcom, Inc. | 2015-09-23 |
| FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS (P960004/S073) | Boston Scientific | 2015-09-23 |
| XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S075) | Abbott Vascular | 2015-09-23 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S122) | W. L. Gore & Associates, Inc. | 2015-09-23 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S230) | Boston Scientific Corp | 2015-09-22 |
| TRIFECTA VALVE (P100029/S020) | ABBOTT MEDICAL | 2015-09-22 |